DiabetesPhase 1NCT01152372
Experimental Study to Validate the Modified Glucose Disposal Test
A Phase 1 study testing Insulin, glucose and staple isotopes in people with Diabetes, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Insulin, glucose and staple isotopes
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Type 2 diabetes
- Clinically healthy
- Drug naive or on a stable dose of metformin monotherapy and/or a secretagogue
Who cannot join
- Type 1 Diabetes
- History of significant heart disease.
- Bariatric surgery
- Exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or DPP-IV inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute For Clinical Research, Inc. (Picr)
Chula Vista, California, 91911
About this study
Official title: Experimental Medicine Study to Validate the Modified Glucose Disposal Test in Healthy Subjects and Subjects With Type 2 Diabetes
Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus
- Conditions
- Diabetes
- Being tested
- Insulin, glucose and staple isotopes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin, glucose and staple isotopesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Beta cell function by frequently sampled intravenous glucose tolerance test Receives: Procedure: Insulin, glucose and staple isotopes |
| Arm 2 | Other | Modified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion Receives: Procedure: Insulin, glucose and staple isotopes |
| Arm 3 | Other | Endogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp Receives: Procedure: Insulin, glucose and staple isotopes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion
Measured: within 24 hours
Secondary outcomes (1)
Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152372
- Sponsor's protocol ID
- MB122-003
- Status last verified
- Aug 2010
- First submitted
- 16 Jun 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Medicine Study to Validate the Modified Glucose Disposal Test in Healthy Subjects and Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01152372
- Acronym / sponsor ID
- MB122-003
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Insulin, glucose and staple isotopesBeta cell function by frequently sampled intravenous glucose tolerance test |
| Arm 2 | Other | Procedure: Insulin, glucose and staple isotopesModified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion |
| Arm 3 | Other | Procedure: Insulin, glucose and staple isotopesEndogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Type 2 diabetes
- Clinically healthy
- Drug naive or on a stable dose of metformin monotherapy and/or a secretagogue
Key exclusion criteria (4 listed)
- Type 1 Diabetes
- History of significant heart disease.
- Bariatric surgery
- Exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or DPP-IV inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin, glucose and staple isotopes | Procedure or surgery | Arm 1, Arm 2, Arm 3 |
Primary outcome
Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion
Time frame: within 24 hours
1 secondary outcome
Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus
Time frame: within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin, glucose and staple isotopes in people with Diabetes, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion (time frame: within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.